MAN-04008-001 Rev. 001 Page 24 of 27
Table 29: Between-Instrument Precision
ThinPrep 5000 ThinPrep 2000*
Percent of specimens that have three
matching NILM replicates or three
matchin
ASC-US+ replicates
94.0%
(110/117)
(88.2% to 97.1%)
91.1%
(102/112)
(84.3% to 95.1%)
Percent of specimens that have three
matching <LSIL replicates or three
matchin
LSIL+ re
licates
97.4%
(114/117)
(92.7% to 99.1%)
94.6%
(106/112)
(88.8% to 97.5%)
Percent of specimens that have three
matching <HSIL replicates or three
matchin
HSIL+ replicates
98.3%
(115/117)
(94.0% to 99.5%)
100%
(112/112)
(96.7% to 100%)
Percent of specimens that have three
matching Satisfactory replicates or
three matchin
UNSAT replicates
98.3%
(117/119)
(94.1% to 99.5%)
98.3%
(113/115)
(93.9% to 99.5%)
* 120 specimens were enrolled, but 5 were excluded due to slide breakage and other errors.
Cell Count Study
The quantity of cellular material transferred onto slides, comparing ThinPrep 5000 to the ThinPrep
2000, was evaluated in a laboratory study using a split-sample technique.
Two hundred ten (210) specimens were enrolled in the study (139 NILM, 28 ASC-US, 28 LSIL, and
15 HSIL). Each specimen was split into two parts, processed on a ThinPrep 2000 and ThinPrep 5000
system, then stained and coverslipped. All slides were run on a ThinPrep Imaging System to obtain
Imager object count data, which has been demonstrated to correlate closely with cytotechnologist cell
count estimates. Cellularity varies among clinical specimens, so a range of cell counts was obtained.
The chart below provides a scatter plot of the count data from the matched pairs of slides in this
study. The Control axis is the ThinPrep 2000 slide’s count value, and the Test axis is the matching
ThinPrep 5000 slide’s count.
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